Comparison of Lateralized RTSA With and Without Subscapularis Repair

Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair

The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.

The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:

Specific Aim 1:

To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 2:

To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.

Specific Aim 3:

To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 4:

To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 5:

To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.

Inclusion Criteria:

• Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
• First RTSA implantation
• Absence of neoplastic diseases at the treated site
• Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group

Exclusion Criteria:

• Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
• Avascular necrosis
• Post-infectious arthritis
• Proximal humerus fracture
• Inflammatory arthritis
• Inability to communicate in English
• Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)

Intra-operative Exclusions:

• Subscapularis with fatty infiltration (Goutallier ≥ 3)
• Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
• Any anatomical or patient characteristic that warrants a non-lateralized implant